Senior Regulatory Affairs Specialist (Medical Devices)

Location: US Remote

Salary: $83,000–$103,700 USD per year

Company

hirify.global develops cell-free DNA testing and personalized genetic diagnostics for oncology, women’s health, and organ health.

What you will do

• Prepare, execute, and manage regulatory submissions for new and modified medical devices and in vitro diagnostic devices.
• Develop FDA and international submission strategies, regulatory options, and risk assessments.
• Prepare U.S. submissions including 510(k)s, PMA applications and supplements, PDPs, IDEs, and Pre-Submissions.
• Coordinate responses to regulatory agency requests and interact with U.S. regulatory agencies.
• Review clinical protocols, monitor clinical study status, and assess clinical data for regulatory decisions.
• Review product release documents, labels, labeling, and promotional materials for regulatory compliance.

Requirements

• Bachelor’s degree or equivalent; biological sciences, chemistry, or a related scientific field is strongly preferred.
• At least 5 years of experience in the device, diagnostic, biologic, and/or pharmaceutical industry, preferably in regulatory affairs.
• Current knowledge of U.S. medical device and in vitro diagnostic regulatory requirements, GLP, and QSR.
• Knowledge of European medical device and IVD requirements and European quality system standards.
• Strong verbal and written communication, organization, and project management abilities.
• Completion of HIPAA/PHI privacy, compliance, and security training within the first 30 days of hire.

Culture & Benefits

• Medical, dental, vision, life, and disability insurance for eligible employees and dependents.
• Free testing for employees and immediate family members, plus fertility care benefits.
• Pregnancy and baby bonding leave, 401(k), commuter benefits, and an employee referral program.
• Collaborative work with statisticians, geneticists, physicians, laboratory scientists, business professionals, and software engineers.